Kintor Pharmaceutical has concluded subject enrolment in the Phase II clinical trial of KX-826 (pyrilutamide) to treat male androgenetic alopecia (AGA) patients in the US.
For the double-blind, parallel-group, randomised, placebo-controlled, Phase II trial, the company recruited 121 subjects.
The study has been designed to assess KX-826’s safety and efficacy to treat adult males with AGA, which is hair loss caused by excessive androgens production.
The change in non-vellus target area hair counts (TAHC) at week 24 from baseline in comparison to placebo will be the trial’s primary endpoint.
Kintor Pharma founder, chairman, and CEO Dr Youzhi Tong said: “About 83 million men and women in the US are suffering hair loss and the number in China has exceeded 252 million, hair loss is gradually becoming the focus of the whole society.
“As a topical AR antagonist, KX-826 has showed a good efficacy and safety profile in our phase II clinical trial in China for the treatment of AGA in male patients.
“We look forward to accelerating the clinical process of KX-826 to the benefit of those that suffer from hair loss.”
The androgen receptor (AR) antagonist, KX-826, is a potential first-in-class topical drug which has been developed to treat AGA and acne vulgaris.
In September last year, the company reported that the Phase II clinical trial of KX-826, which was conducted in adult male AGA patients in China, met the primary endpoint.
The findings demonstrated that KX-826 was well-tolerated and had positive safety profile.
At present, the company is also conducting a Phase III clinical trial of KX-826 for male AGA patients and Phase II trial for female AGA patients in China.
In May this year, Kintor dosed the first participant in the US under its Phase II clinical trial of ALK-1 antibody (GT90001) and Nivolumab (Opdivo) combination therapy to treat advanced hepatocellular carcinoma (HCC).